510(k) K053244

LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT by Integra Lifesciences Corp. — Product Code GWM

K053244 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT". The FDA issued a decision of Substantially Equivalent on May 10, 2006. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.